A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation
• Measurable disease by RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Locations
United States
California
The Angeles Clinic and Research Institute - West Los Angeles Office
RECRUITING
Los Angeles
University of California San Diego Moores Cancer Center
RECRUITING
San Diego
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
New York
Columbia University Irving Medical Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Texas
Sarah Cannon Research Institute at Mary Crowley
RECRUITING
Dallas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
NEXT Oncology
RECRUITING
San Antonio
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Contact Information
Primary
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
tbbo11818-101ct.gov@bbotx.com
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2029-09
Participants
Target number of participants: 387
Treatments
Experimental: Cohort 1a - Dose Escalation Monotherapy
Participants enrolled in this cohort will receive BBO-11818 as monotherapy
Experimental: Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab)
Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)
Experimental: Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed)
Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV)
Experimental: Cohort 1d - Dose Escalation Combination Therapy (Cetuximab)
Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)
Experimental: Cohort 1e - Dose Escalation Combination Therapy (FOLFOX + Cetuximab)
Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) and FOLFOX infusion (IV)
Experimental: Cohort 1f - Dose Escalation Combination Therapy (NALIRIFOX)
Participants enrolled in this cohort will receive BBO-11818 in combination with NALIRIFOX infusion (IV)
Experimental: Cohort 1g - Dose Escalation Combination Therapy (Gemcitabine + Nab-Paclitaxel)
Participants enrolled in this cohort will receive BBO-11818 in combination with Gemcitabine infusion (IV) and Nab-Paclitaxel infusion (IV)
Experimental: Cohort 2a - Dose Expansion Monotherapy
Participants enrolled in this cohort will receive BBO-11818 as monotherapy
Experimental: Cohort 2b - Dose Expansion Combination (Pembrolizumab)
Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)
Experimental: Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed)
Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV)
Experimental: Cohort 2d - Dose Expansion Combination Therapy (Cetuximab)
Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)
Experimental: Cohort 2e - Dose Expansion Combination Therapy (FOLFOX + Cetuximab)
Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) and FOLFOX infusion (IV)
Experimental: Cohort 2f - Dose Expansion Combination Therapy (NALIRIFOX)
Participants enrolled in this cohort will receive BBO-11818 in combination with NALIRIFOX infusion (IV)
Experimental: Cohort 2g - Dose Expansion Combination Therapy (Gemcitabine + Nab-Paclitaxel)
Participants enrolled in this cohort will receive BBO-11818 in combination with Gemcitabine infusion (IV) and Nab-Paclitaxel infusion (IV)
Related Therapeutic Areas
Sponsors
Leads: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)